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Fibroids cause pain and heavy menstrual bleeding in some women who have them, but others experience no symptoms.

Women’s health advocates have long battled for wider recognition of the problems caused by fibroids, noncancerous growths on the uterus that can cause bloating, discomfort and heavy menstrual bleeding.

Getting women to talk about their fibroids has been viewed as a way to break the stigma around the condition and encourage more research and better treatment options, beyond fertility-robbing hysterectomies.

But now, even as fibroids are poised to enter the national conversation like never before, some women’s health advocates are bracing for a potential downside from the discussion. With “fibroid awareness” on the rise thanks to a Big Pharma campaign to stoke sales of a new prescription drug, they warn that marketing-oriented messages could lead to some women to get costly treatment they don’t need and could harm them.

Drug marketers planning ‘a lot of education’

Fibroids are extremely common–some studies show most women have them at some point during their reproductive years. But they usually remain small and harmless. For those with bothersome symptoms, a range of treatment options has come on the scene to shrink or remove them.

Forthcoming hormone-blocking drugs might be a useful new tool to quash symptoms, allowing women to avoid surgery to remove tumors. The first of these, Allergan’s ulipristal, is expected to reach the U.S. next year. It’s already sold in Europe and Canada for long-term intermittent use, at a cost of about $10 per pill. Other products are in development by AbbVie and Neurocrine Biosciences.

Allergan is boasting to investors that it’s planning “a lot of education” to pump up sales of the drug, marketed in Europe as Esmya. FiercePharma reported in an interview with Allergan’s marketing chief, Bill Meury, that the company is planning to deploy an “army” of 300 sales reps to call on obstetrician/gynecologists and a direct-to-consumer ad campaign including TV, print and social media that will put its drug “front and center.”

Allergan is laying groundwork by funding a patient advocacy group, the White Dress Project, which is trying to establish a national “uterine fibroid awareness month.” The founder of that advocacy group is featured in the first of a series of video patient stories Allergan says will “help build awareness of the fibroid patient journey.”

“So many women with fibroids suffer in silence, assuming it’s a normal byproduct of being a woman, and that there is little that can be done,” White Dress Project founder Tanika Gray Valbrun said in an Allergan news release. “It’s very encouraging that an organization like Allergan has stepped up to help us drive the much-needed disease-state recognition, which will help more women feel supported by a community that better understands the suffering they may experience with fibroids.”

Gray Valbrun, whose LinkedIn profile describes her as Content Producer at CNN, did not return a call requesting comment.

‘It’s not a public health message. It’s a sales message.’

No doubt some women with symptomatic fibroids need more support and understanding. But while patient groups have good intentions, drug companies often push messages that stoke unwarranted fears and expand the definition of disease in order to make normal conditions seem like they require treatment.

Cindy Pearson

Allergan’s video heralds the fact that 26 million U.S. women “could be affected by uterine fibroids,” and millions “may experience associated symptoms or health issues.” But it doesn’t say how many of those women might actually benefit from a new treatment option. Again, experts say that most women with fibroids don’t require treatment at all.

Women have suffered harm from industry-funded awareness campaigns for years, noted Cindy Pearson, executive director of the National Women’s Health Network, an advocacy group that does not accept money from drugmakers, device companies or health plans.

“It sure looks like Allergan is over-promoting, which almost certainly leads to use by people who don’t need it and for whom the benefit really hasn’t been shown,” Pearson said. “It’s not a public health message. It’s a sales message.”

So far there’s limited safety data on ulipristal. The longest safety study followed just 64 patients for an average of four years. It had no comparison group, used only patients that had already been successfully treated with the drug, and was funded and designed by the drug’s European distributor, which had an obvious interest in getting a positive result. Moreover, only four percent of the patients in that study were black women. As a group, black women are much more likely to have severe fibroids than white women.

More studies are needed to show how well it works for minority women, cautioned researchers at Whipps Cross University Hospital in London, who wrote that “there is no outcome evidence for women to make informed choices for their individual circumstance.”

Pearson hopes the Food and Drug Administration will conduct an advisory committee meeting on Allergan’s application, which would make public more information on the evidence for its safety and efficacy including independent analyses.

Fertility fears are a perfect target for marketers

A public education campaign — even one funded by the drug industry — could be helpful if it wipes away the taboo of talking about menstrual problems, helps women access appropriate care, and raises awareness of all available treatments, said Karen Carlson, M.D., director emerita of Women’s Health Associates at Massachusetts General Hospital, who’s a HealthNewsReview.org contributor.

But Carlson added in an email: “It is not clear that the [Allergan] PR campaign will meet these criteria: there is a strong commercial incentive to skew the information in a direction that leads women to specifically seek this drug at the exclusion of other options.”

One big concern, Carlson said, is whether drug marketing will “amp up” concerns about the unclear impact of fibroids on fertility. The effects of fibroids on fertility are complex, she said, and depend on their size and location.

Karen Carlson, MD

“Women who want to have a baby in the future are often highly motivated to protect and enhance their fertility, and are perfect targets for marketing campaigns that offer new products and services to help them do so,” Carlson said. “It’s unclear whether the [Allergan] campaign will veer in the direction of pushing ‘early detection’ (and treatment) of fibroids to protect future fertility, but to the extent that it does, that will raise questions about whether its intent is to raise awareness or sell its product.”

An Allergan spokesman wouldn’t say whether the company intends to market ulipristal as a way to protect fertility. He sent a statement saying the FDA’s ongoing review of the drug means it’s “premature and inappropriate at this time to comment on specific commercial or promotional plans.”

But Allergan has already recruited a fertility doctor to promote the product. She was quoted in a news releasetoutingits application to the FDA:

“Uterine fibroids have a serious impact on public health, and I am hopeful ulipristal acetate will offer millions of women a new, non-surgical treatment option that will help them manage their uterine fibroids,” said Millie A. Behera M. D., FACOG, Reproductive Endocrinology and Fertility Medical Director, Bloom Reproductive Institute. “It is welcome news for physicians to learn about the possibility of an oral treatment option, and that’s exactly what U.S. physicians can look forward to if the investigational drug ulipristal acetate is approved for abnormal uterine bleeding in women with uterine fibroids.”

Patient stories as stealth promotion

Fear is an effective marketing strategy, and it can have dismal consequences. In the 1990s makers of osteoporosis drugs pushed for screening that led many women with slightly diminished bone mineral density to believe they were at risk of breaking a bone and needed to take drugs. As it turns out, those drugs provided only modest benefits yet caused serious consequences, including increased risk of some rare but serious bone fractures over time.

Similarly, portraying menopause as a scary time of hormone depletion revved up demand for hormone replacement therapy, which was eventually linked to a moderate increase in women’s risks of some bad outcomes such as stroke, dementia and breast cancer death. The drugs were supposed to reduce menopausal symptoms such as hot flashes, vaginal dryness and night sweats but with goading from the drug industry, physicians expanded their prescribing for “off-label” uses not approved by regulators, such as protection against heart disease.

Patient stories including celebrity endorsements allow drugmakers to promote fear and expand the sale of drugs beyond their proven uses, Pearson said. “It’s a way of conveying exaggerated messages that a company itself wouldn’t get away with saying (because of FDA oversight). A patient can say whatever she believes, whether that’s backed up by science or not,” Pearson said. “And our empathy leads us to want to believe them.”

Often these stories get echoed in the media.

Will fear-mongering coverage cross the Atlantic?

Coverage that exaggerates the impact of fibroids has already shown up in Europe, where Allergan’s drug has been available since 2012. An article in the London Daily Mail depicted a woman with a distended stomach, entitled “Agony of woman who battled tumors that plague 1 in 3 women — and can wreck lives.” It touts Esmya as a drug that can “spare thousands of women from invasive surgery.”An article in the UK Express called Esmya a “miracle pill” and focused on the story of one woman with severe fibroids who credits the drug with saving her fertility.

There’s good reason to expect an uptick in U.S. coverage of fibroids. HealthNewsReview.org recently reviewed a Wall Street Journal article, “New Treatment for Fibroids Without Surgery,” that did an excellent job of exploring the many different options available to treat this condition — and emphasizing that most women with fibroids don’t need treatment. However, it didn’t disclose Allergan’s backing for the White Dress Project, whose founder was featured prominently in the coverage. (Our reviewers were also unaware of Allergan’s support at the time they conducted their review.)

A Philadelphia Inquirer business story, “Hoping for FDA approval: The first pill to treat bleeding from uterine fibroids,” focused mainly on the drawbacks of other fibroid approaches and leaned heavily on an Allergan news release. Independent sourcing may have helped balance the story with a caution about the potential for overtreatment.

What to Look for in Fibroid Stories

The prospect of a forthcoming FDA approval will likely keep fibroids high on health care journalists’ radar. Here are steps reporters can take to provide proper context — and which consumers should be looking for in any story about new fibroid treatments:

Explain whether there’s good data to show a drug is safe, particularly if it’s approved for long-term use rather than a one-off prior to surgery.

Emphasize that most fibroids don’t require treatment, and fibroids shrink on their own during menopause.

Ask whether physician, patient and celebrity advocates receive money or gifts from the drug’s maker or earn money from fibroid treatments of any kind. Be sure to include perspective from experts with no ties to the pharmaceutical industry.

With fibroids, it’s also important not to succumb to scary language.

“It isn’t contagious, and it is not a growing problem. It’s just problematic for a decent number of people,” Pearson said. “If pain and heavy bleeding aren’t bothering you, turn the page.”

Comments (2)

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Lyn Stoler

November 18, 2017 at 7:08 pm

While this piece clearly explains the risks and repercussions of Allergan’s upcoming fibroid awareness campaign, there was little discussion about why this campaign may be happening in the first place. Despite the financial motivations that pharmaceutical companies hold, this campaign is simply a reaction to the policies and programs the US has in place with respect to the drug industry.

All of the public health claims that the author, Mary Chris Jaklevic, made were likely well-founded. However, they are framed in a way that ignores the central issue surrounding pharmaceuticals. While their techniques may be inappropriate, as public health practitioners we must ask ourselves- Why are pharmaceutical companies marketing so aggressively to vulnerable patients in the first place?

Firstly, we must remember the fundamentals of drug research and development. The drug pipeline begins with thousands more potential candidates than the drugs that we see on the market. This is because the FDA approval process, rightfully geared towards protecting patients, requires multi-stage rigorous safety and efficacy trials. Each potential drug candidate that does not make it to market incurs significant costs for pharmaceutical companies. Therefore, successful drugs like Esmya must not only recoup the costs of their own R&D, production, and distribution; they must also be profitable enough to regain the costs associated with any drugs that did not make it to market. The structure of R&D in the US puts pressure on pharmaceutical companies to heavily market their successful drugs to maximize profits and regain costs.

However, the drug development structure alone does not lead to aggressive drug marketing. In our country, it is paired with a fee-for-service payment system. This system means that Allergan gets paid per dose of Esmya that is prescribed and administered. Allergan is thus incentivized to maximize public use and demand for their product. An alternative that removes this incentive would be a value-based payment system. Under a value-based system, an insurance company would pay Allergan a monthly rate for the ability to use Esmya whenever they needed. Payment would be calculated using a formula based on the number of women that are at risk for uterine fibroids that require treatment, and their cost of treatment. In this model, all at-risk women will be accounted for in the payment model, yet Allergan would only need to provide Esmya to those who require treatment in any given month. Therefore, they are actually incentivized to not overprescribe, since they would be paid equally for only providing Esmya to women that truly need it.

Now we must turn to the targets of Allergan’s marketing and awareness campaign- women at risk of uterine fibroids. What about our culture would make such a resource-intensive marketing campaign so appealing to Allergan?

The United States is dominated by a singular obsession with choice, and the ability of the consumer to make their own decisions. In this case, consumerism takes the form of patients taking autonomy over their own healthcare. This autonomy is arguably better for patients who may otherwise feel little control over their own health, but it also impacts the patient-doctor relationship and the doctor-pharmaceutical company relationship. When the patient has the ability to make the final decisions on their treatment plan, doctors are less likely to deny them any procedures or pharmaceuticals they choose. This makes patients a key point of contact for Allergan as it promotes Esmya. Raising awareness among women may create a demand that inevitably leads to higher sales, in large part due to the consumerism-driven patient-doctor relationship.

This culture’s impact on the doctor-pharmaceutical company relationship only serves to strengthen the results of marketing campaigns. The United States has a decentralized healthcare system, where the decision of whether or not drugs are prescribed is often left to the individual doctor, as opposed to a centralized body like Great Britain’s National Health Service. This means that marketing aggressively to doctors will likely increase the number of prescriptions they write for Esmya, especially when paired with pressure from patients that have been targeted by the fibroid awareness campaign.

While it’s hard to ignore the often inappropriate targeting and messaging that these awareness campaigns may use, it’s also reductive to ignore the political and cultural factors that lead companies like Allergan to these methods. The awareness campaign that Allergan has begun is not inherently negative; the potential repercussions that are associated with overprescription of Esmya is the root of much public health concern surrounding the topic. With the ball rolling on this campaign, how can we navigate this political sphere to ensure that it does not have negative public health effects?

Public health resources would have to be dedicated to the cause. The effectiveness of this awareness campaign lies largely in the lack of knowledge and certainty surrounding uterine fibroids. Increased funding and focus of research on uterine fibroids, who they affect most, and who truly needs treatment would help to minimize inappropriate prescription. In addition, increasing and sustaining access to female reproductive services will help to ensure that the conversation surrounding fibroids is informed by more than a campaign run by a pharmaceutical company. Lastly, it is critical that longer-term post-market effectiveness and safety trials be conducted surrounding the effects of Esmya.

These steps will be critical for those who want to contain the effects of Allergan’s campaign. However, they are focused on a downstream manifestation of the policies and programs that have led to this campaign. Rather than funneling limited public health resources towards every new issue that arises from pharmaceuticals, it is imperative that we look to the systemic factors that give rise to them.

It is unlikely that America’s consumer-driven healthcare culture will ever change, since it is so closely linked to American ideals of individualism. However, it is more likely that we may address both the FDA approval process and drug payment structures through policy to prevent marketing campaigns such as this in the future.

The FDA approval process has often been criticized for being too overbearing, and thus putting too many costs on pharmaceutical companies. Although the rigor of safety testing is clearly justified, perhaps a less time and resource-intensive efficacy trial method may be a viable option to reduce costs that are later shifted to patients. This must be paired with much more rigorous post-market effectiveness analysis, and streamlined procedures for removing drugs that perform poorly from the market. However, it may reduce the need for companies like Allergan to so aggressively market their successful drugs.

Lastly, and perhaps most realistically, private sector changes in the insurance payment model could lead to more appropriate drug use. The switch from fee-for-service to a value based payment method is likely the most realistic and timely solution to this problem. Insurance companies, pharmaceutical companies, and patients alike will benefit from this system, and it will prevent inappropriate marketing schemes such as Allergan’s in the future.

These upstream solutions are much more likely to have lasting impacts on our healthcare system, and protect patients as they are forced to make healthcare decisions under a barrage of information from different sources. Rather than blaming drug companies for actions that are understandable given the circumstances, it’s important to take responsibility for the culture we as a nation have created around pharmaceuticals, and address them head on.

Sandra Mukasa

November 19, 2017 at 8:54 pm

$10 vs $90,000. The first number is the projected cost of each ulipristal pill to help manage abnormal uterine bleeding due to fibroids as described by this article. The second number is the medical cost of my myomectomy procedure to remove bothersome uterine fibroids this year. Fortunately, I had health insurance at the time and did not have to pay that full amount, but my out of pocket costs were still over 200 times higher than this drug by Allergan that is undergoing review by the FDA. While there are numerous valid critiques that Jaklevic levels toward Allergan’s building marketing strategy for ulipristal, it is important that in the midst of these health policy discussions we don’t lose sight of how the current limited field of options for fibroid treatment can lead to major financial impacts, not to mention social and emotional impacts, for people with fibroids. If ulipristal had been available and appropriate for my fibroid symptoms, I certainly would have jumped at the opportunity to try this non-invasive treatment. However, we are not at that stage as ulipristal is still undergoing review by the FDA. Instead, we are currently in a time of opportunity and challenge as new treatments for uterine fibroids begin to emerge over the next few years and we must decide how to set health policy in relation to these drugs. Jaklevic’s article raised a number of issues related to fibroid drug development, drug marketing and consumer engagement that deserve further attention. First, there is the critique that Allergan has on one of its videos the statement that approximately 26 million US women have fibroids but is not specific about the number of women who would specifically benefit from their new drug. However, it must be acknowledged that there are still large gaps in research about the impacts of fibroids in the population that prevent Allergen from making more precise claims. The prevalence rate, while known to be high, is not precise and symptoms related to fibroids can also shift over time. Therefore, this should not be seen as a case of Allergan being intentionally vague and deceitful about the extent of their potential impact, but that there are true data limitations at this point in time. Second, the article raised concerns regarding new treatments for fibroids resulting in over diagnosis and overutilization of interventions. Although within the general health policy landscape there are longstanding concerns regarding over diagnosis and over treatment leading to high health care expenditure costs, I doubt this will evolve into an overwhelming problem in the case of fibroids. That is largely because as it currently stands, we already have very high expenditures associated with current fibroid treatments. According to the National Institutes of Health, fibroids account for nearly a quarter million hysterectomies (the sole fibroid cure currently available) that are performed each year and direct health costs for fibroids are over $2.1 billion. The introduction of new fibroid treatments that can shrink and/or diminish the symptoms of fibroids will therefore likely lead to a reduction in the expensive surgeries like hysterectomies and myomectomies in the future. This article largely describes over treatment concerns in regards to non-symptomatic fibroids. Yet, oftentimes non-symptomatic fibroids are so small that they are not be detected during a routine pelvic exam and thus people and their health care providers are unaware of their presence. Therefore, over treatment for non-symptomatic fibroids simply cannot occur if they are oftentimes not even diagnosed. We should certainly become more alarmed if Allergan and similar companies made the bold step of lobbying the US Preventative Services Task Force to include yearly uterine ultrasounds as part of the standard level of care during gynecology appointments, even when the patient does not have any existing complaints. A move such as this would certainly increase undue concern about them. However, as it currently stands, the detection of most fibroids mainly occurs when they have grown perceptively large and/or an individual reports bothersome symptoms to their health care provider who then may directed them to have more precise screening. In addition, since many of the symptoms related to fibroids are largely subjective (i.e. heavy period, pain, discomfort, bloating, urinary problems), it is up to the impacted individual to let their health provider know whether symptoms have reached a level that leads them to desire some level of medical or surgical intervention. That begin said, there does exist the possibility of drug companies such as Allergan to shape the public perspectives around gynecological care and fibroid treatments in a way that may encourage potentially unnecessary drug utilization. However, it is possible to systematically temper these market-driven consumption pressures. We can move forward to create a future that better responds to the needs of those with fibroids by focusing attention on those who are most vulnerable to drug overutilization pressures. I propose we do this by having a comprehensive fibroid public education campaign funded by the US government. A widespread fibroid education campaign led by entities that are not drug makers are sorely needed. While there are several advocacy groups with fibroids related initiatives, they do not have the same resources and reach as the government. Government health institutions such as the CDC, NIH, or FDA are best positioned to lead a wide campaign in a non-biased manner. As the original article noted, nearly 80% of women are expected to experience fibroids by the time they are 50 years old. However, public discourse on the subject is sparse. Reviews of the CDC and NIH websites reveal that the current presentation of information on uterine fibroids is unimpressive. Reflecting on my own experiences, it is a shame that even though I work in the public health arena, I only learned about the extent of their impact on public health once I was diagnosed with them. Now is the perfect opportunity for broadening patient knowledge and consumer engagement regarding fibroids before numerous new drugs are approved by the FDA in the near future. The sooner that publically funded campaigns are developed, the easier it will be to temper market-driven narratives by drug companies that are compelled to increase drug revenues. Since fibroids impact such a large portion of the population, the broader public should be informed about the current landscape for fibroid management and treatment and how it may change in the near future. It will be harder for drug companies to employ fear-based tactics to drive up their sales if there is a well-informed public that understands the nuances of fibroids. A comprehensive fibroid education campaign should specifically note what the variety of symptoms are and their related appropriate treatments. This information could be presented in a decision-tree treatment matrix to facilitate better patient and doctor communication. I can attest that such a health education tool would have been highly valuable to me and others that I know as we researched fibroid treatment options. As new drugs are approved by the FDA, they can be incorporated into the treatment matrix and reduce the likelihood of misinformation. For example, ulipristal, is talked about broadly as a fibroid drug treatment in this article when it only treats symptoms related to abnormal uterine bleeding. Therefore, symptoms such as lower back pain or urinary problems would not be impacted by this drug. Without a truly broad education campaign, too many people will first learn about the existence of fibroids from drug company advertisements, which may bias them towards a particular treatment arm that may not be beneficial. The best way to control a narrative is to shape it; therefore, we should not wait to play defense against messaging by drug companies that may overemphasis their products to a concerned public. Through agencies such as the CDC, NIH, and FDA, the government can and should provide relevant and accessible information regarding fibroids through a comprehensive public education campaign.

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